Fortified Hospital Food as Nutritional Support

NCT ID: NCT01415635

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-02-29

Brief Summary

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Background:

The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.

The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.

Methods:

The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.

Detailed Description

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Conditions

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Malnutrition

Keywords

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Nutritional risk, Hospital food, Nutritional Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nutritional intervention

The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital")(intervention group).

Group Type EXPERIMENTAL

Nutritional intervention using

Intervention Type DIETARY_SUPPLEMENT

The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").

Interventions

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Nutritional intervention using

The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* patients at nutritional risk, according to the NRS-2002 system
* patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
* well-functioning gastrointestinal tract
* anticipated length of hospitalization of more than 3 days

Exclusion Criteria

* terminal patients
* dysphagia
* food allergy or intolerance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tina Munk, MSc.

Role: STUDY_DIRECTOR

Herlev University Hospital, Denmark

Locations

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Herlev University Hospital

Herlev, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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Hansen MF, Nielsen MA, Biltz C, Seidelin W, Almdal T. Catering in a large hospital--does serving from a buffet system meet the patients' needs? Clin Nutr. 2008 Aug;27(4):666-9. doi: 10.1016/j.clnu.2008.05.004. Epub 2008 Jul 14.

Reference Type BACKGROUND
PMID: 18621450 (View on PubMed)

Other Identifiers

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H-1-2011-048

Identifier Type: -

Identifier Source: org_study_id